Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT06692894
Status:
RECRUITING
Last Update Posted:
2024-12-05
First Post:
2024-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Defining Inflammatory Markers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples will be processed to test DNA from serum.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biologic Variability of Markers of Inflammation in the Blood', 'timeFrame': 'over 6 months', 'description': 'The within- and between-person biologic variability of an inflammation proteome over a period of 6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myelodysplastic Syndromes', 'Hematology'], 'conditions': ['Myelodysplastic Syndromes, Adult']}, 'descriptionModule': {'briefSummary': 'Why Is This Research Study Being Conducted?\n\n* The study wants to find out why people with a type of blood cancer called myelodysplastic syndromes (MDS) are more likely to have heart problems like heart disease and stroke.\n* Researchers also want to see if certain proteins related to inflammation in the body can help predict these heart issues in MDS patients.\n* By understanding this better, researchers hope to find new ways to detect and manage heart disease risks in people with MDS', 'detailedDescription': "What Is Involved in The Study?\n\n* This study will follow patients with MDS over 6 months.\n* Participants will come to the hospital for the first visit. Participants will learn about the study, sign papers to join the study, and share some basic health information. Participants will also give a blood sample of 10 milliliters after not eating overnight.\n* After the first visit, participants will come back to the hospital once a week for 3 weeks to give more blood samples after fasting overnight.\n* The study team will call participants the day before each scheduled blood draw to remind you of your appointment.\n* Then participants will return to the hospital for another visits once a month for the next 5 months. Participants will talk about any changes in their health and give a blood sample at each visit.\n* Participants won't get any treatment as part of this study, but their participation will help researchers learn how inflammation affects the health of people with MDS\n* Researchers will collect a small amount of blood (6-10 mL) per visit\n* These blood collections are a normal part of medical care and won't require participants to come in more often than usual. The frequency of visits will be part of the routine care for myelodysplastic syndrome at the cancer center. Extra blood will be collected during standard of care blood draws in the clinic.\n* Sessions will take about 20 minutes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with MDS diagnosed and treated at UVMMC will be eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed diagnosis of MDS by bone marrow biopsy morphology, using the 2022 World Health Organization (WHO) classification for myeloid neoplasms\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤3\n* Expected survival of at least 6 months\n* Ability to provide consent\n\nExclusion Criteria:\n\n* Cases meeting 2022 WHO criteria of MDS with excess blasts 2 as initial diagnosis\n* Hematopoietic stem cell transplantation expected within 6 months'}, 'identificationModule': {'nctId': 'NCT06692894', 'briefTitle': 'Defining Inflammatory Markers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont'}, 'officialTitle': 'Defining Inflammatory Biomarkers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes', 'orgStudyIdInfo': {'id': 'STUDY00003256/UVMCC2406'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with Myelodysplastic syndromes', 'description': 'All participants will be in one group. Participants will by adults with Myelodysplastic syndromes. Blood will be taken at regular appointments that are part of standard care.', 'interventionNames': ['Other: Observational']}], 'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'Blood will be collected from one cohort to identify potential blood biomarkers.', 'armGroupLabels': ['Adults with Myelodysplastic syndromes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05495-2038', 'city': 'Burlington', 'state': 'Vermont', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diego Adrianzen Herrera, MD', 'role': 'CONTACT', 'email': 'dadrianz@uvm.edu', 'phone': '802-656-4414'}, {'name': 'Diego Adrianzen Herrera, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'centralContacts': [{'name': 'Diego Adrianzen Herrera, MD', 'role': 'CONTACT', 'email': 'dadrianz@med.uvm.edu', 'phone': '(802) 656-2021'}, {'name': 'Neil A Zakai, MD', 'role': 'CONTACT', 'email': 'neil.zakai@med.uvm.edu', 'phone': '(802) 656-2021'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Oncologist, Assistant Professor', 'investigatorFullName': 'Diego Adrianzen Herrera', 'investigatorAffiliation': 'University of Vermont'}}}}